AccessGUDID - DEVICE: GEM COUPLER Microvascular Anastomotic Instrument (00844735005233)

GUDID

Device Identifier (DI) Information

Brand Name: GEM COUPLER Microvascular Anastomotic Instrument
Version or Model: GEM2740
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 519303002010
Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC

Primary DI Number: 00844735005233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031284586 *Terms of Use

Device Description: A reusable Instrument designed to hold the GEM COUPLER device and approximate the GEM COUPLER rings during vessel anastomosis

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61238	Vascular anastomosis coupling approximator	A non-sterile, hand-held manual surgical instrument designed for use during vascular (including microvascular) anastomosis surgical procedures to hold the rings of a vascular anastomosis coupler while the blood vessel ends are secured to the rings, and then to approximate the rings to create the anastomosis. It is made of metal. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1b816b2-f50a-4d44-a995-5eb14ba01141
Public Version Date: July 27, 2023
Public Version Number: 7
DI Record Publish Date: September 24, 2016